Parkinson's DiseasePDEWSNCT02217735
Expressive Writing for Individuals With Parkinson's Disease and Their Caregivers
A study testing Writing Intervention in people with Parkinson's Disease and Coping Skills, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This randomized, controlled trial (RCT) evaluates the benefits of expressive compared to neutral writing in individuals with Parkinson's Disease and their support persons. Participants will be randomly assigned to complete three, 20 minute sessions of expressive or neutral writing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Coping Skills
- What is being tested?
- Writing Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson's Disease Caregiver of an individual with Parkinson's Disease
Who cannot join
- Clinical diagnosis of Dementia Clinical diagnosis of other Parkinson's Disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing
Trial locations and contacts
1 site in 1 country.
United States1 site
VCU Parkinson's and Movement Disorders Center
Richmond, Virginia, 23230
About this study
Official title: Randomized Controlled Expressive Writing Pilot in Individuals With Parkinson's Disease and Their Caregivers
This randomized, controlled trial (RCT) evaluates the benefits of expressive compared to neutral writing in individuals with Parkinson's Disease and their support persons. Participants will be randomly assigned to complete three, 20 minute sessions of expressive or neutral writing. Participants will complete evaluation of outcomes at baseline, immediate post, 4 month and 10 month follow ups to establish if benefits remain over time. Impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. Expressive writing is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the neutral writing condition.
Results from this study will determine whether brief writing exercises are easily used by and beneficial for individuals with Parkinson's Disease and their support persons. If positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with Parkinson's Disease and their support persons.
Read the detailed description
The expressive writing condition asks participants to write about the most stressful or traumatic experience of their entire lives over three, 20 minute private writing sessions. The neutral control writing conditions asks participants to write about how they spent their time the day before.
- Conditions
- Parkinson's Disease, Coping Skills
- Being tested
- Writing Intervention
- Keywords
- Parkinson's Disease, Caregivers, Expressive Writing, Complementary Medicine, Cortisol
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Writing InterventionBehavioural
Participants wrote for 20 minutes on three occasions about an emotional or traumatic topic (expressive writing intervention condition) or what they did the day before, while refraining from including emotional details.
| Study group | Role | What they receive |
|---|---|---|
| Writing Intervention - Expressive Arm | Experimental | Participants are asked to write about the most traumatic or stressful experience of their entire lives in three, 20 minute writing sessions. Receives: Behavioral: Writing Intervention |
| Writing Intervention - Neutral Arm | Active comparator | Participants are asked to write about what they did the day before, refraining from including emotional details. Receives: Behavioral: Writing Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson's Disease Quality of Life (PDQ-39)
Measured: Baseline to immediate post
Secondary outcomes (2)
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Measured: Immediate post to 4-month follow up
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Measured: 4 month follow up to 10 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah K. Lageman, Ph.D., Principal investigator, Virginia Commonwealth UniversityJames P. Bennett, M.D., Ph.D., Study chair, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217735
- Sponsor's protocol ID
- HM#13659
- Acronym
- PDEWS
- Status last verified
- Oct 2023
- First submitted
- 13 Aug 2014
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Cash TV, Lageman SK. Randomized controlled expressive writing pilot in individuals with Parkinson's disease and their caregivers. BMC Psychol. 2015 Nov 30;3:44. doi: 10.1186/s40359-015-0101-4.
PubMed 26621025
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Expressive Writing Pilot in Individuals With Parkinson's Disease and Their Caregivers
- ClinicalTrials.gov ID
- NCT02217735
- Acronym / sponsor ID
- PDEWS / HM#13659
- Conditions
- Parkinson's Disease, Coping Skills
- Keywords
- Parkinson's Disease, Caregivers, Expressive Writing, Complementary Medicine, Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, controlled trial (RCT) evaluates the benefits of expressive compared to neutral writing in individuals with Parkinson's Disease and their support persons. Participants will be randomly assigned to complete three, 20 minute sessions of expressive or neutral writing. Participants will complete evaluation of outcomes at baseline, immediate post, 4 month and 10 month follow ups to establish if benefits remain over time. Impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. Expressive writing is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the neutral writing condition.
Results from this study will determine whether brief writing exercises are easily used by and beneficial for individuals with Parkinson's Disease and their support persons. If positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with Parkinson's Disease and their support persons.
Detailed description
The expressive writing condition asks participants to write about the most stressful or traumatic experience of their entire lives over three, 20 minute private writing sessions. The neutral control writing conditions asks participants to write about how they spent their time the day before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Writing Intervention - Expressive Arm | Experimental | Behavioral: Writing InterventionParticipants are asked to write about the most traumatic or stressful experience of their entire lives in three, 20 minute writing sessions. |
| Writing Intervention - Neutral Arm | Active comparator | Behavioral: Writing InterventionParticipants are asked to write about what they did the day before, refraining from including emotional details. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Parkinson's Disease Caregiver of an individual with Parkinson's Disease
Key exclusion criteria (1 listed)
- Clinical diagnosis of Dementia Clinical diagnosis of other Parkinson's Disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Writing InterventionParticipants wrote for 20 minutes on three occasions about an emotional or traumatic topic (expressive writing intervention condition) or what they did the day before, while refraining from including emotional details. | Behavioural | Writing Intervention - Expressive Arm, Writing Intervention - Neutral Arm |
Primary outcome
Parkinson's Disease Quality of Life (PDQ-39)
Time frame: Baseline to immediate post
2 secondary outcomes
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Time frame: Immediate post to 4-month follow up
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Time frame: 4 month follow up to 10 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 26621025Cash TV, Lageman SK. Randomized controlled expressive writing pilot in individuals with Parkinson's disease and their caregivers. BMC Psychol. 2015 Nov 30;3:44. doi: 10.1186/s40359-015-0101-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah K. Lageman, Ph.D. principal investigator
Virginia Commonwealth University
James P. Bennett, M.D., Ph.D. study chair
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Writing Intervention in people with Parkinson's Disease and Coping Skills, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parkinson's Disease Quality of Life (PDQ-39) (time frame: Baseline to immediate post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02217735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.